BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINDFRAME CAPTURE LP

    MDR report key: 4838732 · Received June 11, 2015

    Report

    Report Number
    2029214-2015-00657
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    April 4, 2015
    Report Date
    May 18, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K141516
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISCARDED. THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER HAS BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED. THE EVENT DESCRIBED APPEARS TO HAVE BEEN PROCEDURE RELATED AS THE DEVICE FUNCTIONED AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED REPORT OF AN EVENT INVOLVING MINDFRAME CAPTURE LP. DURING THE THROMBECTOMY PROCEDURE OF AN OCCLUDED RIGHT M1 OF THE MIDDLE CEREBRAL ARTERY (MCA), WHEN THE DEVICE WAS IN-SITU IN THE ANTERIOR CEREBRAL ARTERY (ACA) THE VESSEL WAS REPORTED TO HAVE SHUT DOWN AS A RESULT OF VASOSPASM. NICARDIPINE WAS GIVEN AND NO FURTHER INTERVENTION WAS REQUIRED FOR THIS EVENT. ONE DEVICE PASS WAS MADE AND TICI 2A WAS ACHIEVED. THE THROMBUS LENGTH WAS REPORTED TO BE THE ENTIRE A2. NO OTHER COMPLICATIONS WERE REPORTED AND NO FURTHER TREATMENT WAS PROVIDED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382852 MINDFRAME CAPTURE LP CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) 300018 150217-003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other